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athersys inc (ATHX) Details

Athersys, Inc., a biotechnology company, focuses on the research and development activities in the field of regenerative medicine. The company’s lead platform product, MultiStem cell therapy, an allogeneic stem cell product, which has Phase I clinical trials for the patients that have suffered an acute myocardial infarction, and leukemia or other blood-borne cancers; and is ongoing Phase II clinical trials for the patients suffering from inflammatory bowel disease (IBD) and ischemic stroke. Its clinical development programs are focused on treating inflammatory and immune disorders, neurological conditions, cardiovascular disease, and other conditions. The company is also involved in identifying and developing small pharmaceuticals to treat obesity; related metabolic conditions, such as diabetes; and neurological indications, including schizophrenia. It has strategic partnership and license agreement with Chugai Pharmaceutical Co., Ltd. to develop MultiStem cell therapy for ischemic stroke in Japan, as well as collaboration agreement with Pfizer Inc. to develop and commercialize MultiStem to treat IBD; and RTI Biologics, Inc. to develop and commercialize biologic implants for orthopedic applications in the bone graft substitutes market. The company was founded in 1995 and is headquartered in Cleveland, Ohio.

athersys inc (ATHX) Key Developments

Athersys, Inc. and Chugai Pharmaceutical Co. Ltd. announced a partnership and license agreement to exclusively develop and commercialize MultiStem cell therapy for ischemic stroke in Japan. Ischemic stroke represents a priority disease area in Japan, given the high healthcare burden of the condition and the expected increase in incidence associated with Japan's aging population. Athersys' proprietary cell therapy product, MultiStem, is currently being evaluated in a Phase 2 clinical study for ischemic stroke in the United States and Europe, and Athersys has begun preparations for clinical development in Japan, including engagement with the Japanese Health Authority. Chugai is a leading research-based pharmaceutical company with strengths in biotechnology products, and brings to the collaboration substantial expertise and experience in late-stage development and commercialization in Japan. As part of the collaboration, Chugai will be responsible for the development and commercialization of MultiStem for ischemic stroke in Japan, and Athersys will have responsibility for product supply. Under the financial terms of the agreement, Athersys will receive an up-front cash payment of $10 million from Chugai and would receive additional payments as the program is further advanced. Athersys is eligible to receive milestone payments from Chugai of up to $45 million upon the successful achievement of certain development and regulatory milestones, and sales milestones of up to 17.5 billion Yen (approximately $150 million based on the current exchange rate). Athersys would also receive from Chugai tiered, double-digit royalties on any net sales, as well as payments for product supplied to Chugai. In Athersys' ongoing Phase 2 clinical study, it is evaluating the administration of MultiStem cell therapy to patients who have suffered an ischemic stroke. Based on preclinical research to date, administration of MultiStem has shown significant benefits through several mechanisms, including reduction of inflammation and immune system modulation in the ischemic area, and the protection and rescue of damaged or injured cells, including neuronal tissue. Athersys is treating patients one to two days after the stroke has occurred, in contrast to thrombolytic tPA treatment, which is limited to the first three to four hours following the stroke. Preclinical studies have demonstrated that administration of a single dose of MultiStem therapy, even one week after a stroke, provides significant and durable improvements relative to controls. Enrollment in Athersys' double-blind, placebo-controlled trial is complete, and interim safety and initial efficacy results following the ninety-day patient data are expected to be announced in April 2015, following analysis and receipt of the unblinded clinical data.

Athersys and Cell Therapy Catapult Announce Grant to Support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory Condition

Jan 22 15

Athersys Limited and the Cell Therapy Catapult announced that Athersys Limited has been awarded a grant from Innovate UK, formerly the Technology Strategy Board, which will support a Phase 2a clinical study evaluating the administration of MultiStemÂ® cell therapy to acute respiratory distress syndrome (ARDS) patients. ARDS is a serious immunological and inflammatory condition characterised by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, or other trauma and represents a major cause of morbidity and mortality in the critical care setting. It has significant implications, as it prolongs intensive care unit (ICU) and hospital stays, and requires convalescence in the hospital and rehabilitation. There are limited interventions and no effective drug treatments for ARDS, making it an area of high unmet clinical need with high treatment costs. Given ARDS high treatment costs, a successful cell therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator, days in the ICU and total days in the hospital, and importantly, could reduce mortality and improve quality of life for those suffering from the condition. The medical need for a safe and effective treatment of ARDS is significant due to its high mortality rate, and it affects annually approximately 33,000 patients in the UK and 400,000 - 500,000 patients in Europe, the United States and Japan, alone. MultiStem cell therapy has demonstrated the capacity to reduce inflammation, support tissue regeneration and promote homeostasis in acute immunological and injury settings. Preclinical data suggests that MultiStem cells may have a protective effect by shifting the physiological response from pro-inflammatory to anti-inflammatory. In animal models, MultiStem cells have demonstrated an ability to reduce the severity of pulmonary distress, reduce alveolar edema and return lung endothelial permeablity to normal.Â Intravenous MultiStem treatment early following the onset of the condition may ameliorate the initial hyper-inflammation and reduce the fibrotic activity that follows, thereby speeding the return to and improving the likelihood of more normal lung function, and helping patient recovery.

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